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Product NDC Code | 77790-001 | ||||
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Drug Name | Vista tears dry relief eye lubricant drops |
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Type | Brand | ||||
Active Ingredients |
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Route | OPHTHALMIC | ||||
Dosage Form | SOLUTION | ||||
RxCUI drug identifier | 477589 | ||||
Application Number | M018 | ||||
Labeler Name | Red Wedding LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions shake well before using Instill 1 or 2 drops in the affected eye(s) as needed close the bottle tightly after use to ensure the stability of the solution Twist cap counterclockwise to break the seal. Unscrew the cap completely. Remove and discard the seal ring.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Hydroxypropyl Guar, glycerol, sodium chloride, potassium chloride, magnesium chloride, calcium chloride, boric acid, sorbitol, aminomethyl propanol, water for injection (WFI), stabilized oxychloro complex 0.01% w/v as a preservative
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for the temporary relief of burning and irritation due to dryness of the eye
Purpose
Information about the drug product’s indications for use.Active ingredients Polyethylene glycol .....Lubricant Propylene glycol.....Lubricant
Spl product data elements
Usually a list of ingredients in a drug product.Vista Tears Dry Relief Eye Lubricant Drops polyethylene glycol 400, propylene glycol HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE AMINOMETHYLPROPANOL CALCIUM CHLORIDE GUARAPROLOSE (1300 MPA.S AT 1%) BORIC ACID POTASSIUM CHLORIDE SORBITOL GLYCERIN MAGNESIUM CHLORIDE WATER SODIUM CHLORIDE PROPYLENE GLYCOL PROPYLENE GLYCOL POLYETHYLENE GLYCOL 400 POLYETHYLENE GLYCOL 400
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Vista Tears Label 77790-001-10 Vista Tears Box 77790-001-10
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if this product changes color or becomes cloudy if seal is broken or punctured
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature (15-30 o C, 59-86 o F). Protect from direct sunlight and freezing temperatures
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult a physician if you experience any of the following: eye pain changes in vision occur irritation or redness for longer than 48 hours
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not touch the tip of container to any surface to avoid contamination replace cap after each use
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnngs For external use only Do not use if this product changes color or becomes cloudy if seal is broken or punctured When using this product do not touch the tip of container to any surface to avoid contamination replace cap after each use Stop use and consult a physician if you experience any of the following: eye pain changes in vision occur irritation or redness for longer than 48 hours Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API